Bristol-Myers Squibb’s immunotherapy Opdivo did not hit the primary target of a late-stage study testing its efficacy in certain patients with small cell lung cancer.

The Phase III CheckMate-331 study assessed Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer (SCLC) who relapsed following chemotherapy.

However, the drug failed to significantly extend overall survival versus chemotherapy in this setting.

On the plus side, no new safety signals were thrown up during the trial, the firm said.

Lung cancer is the leading cause of cancer deaths globally, resulting in nearly 1.8 million deaths each year, according to the World Health Organisation. SCLC accounts for about 10% to 15% of all lung cancer cases.

Chemotherapy is the standard of care in the front-line setting, with or without radiation therapy. However, despite responding to initial treatment, the majority of patients experience relapse within one year.

From the time of diagnosis, the median range of survival for extensive-stage SCLC (ES-SCLC) patients is between eight and 13 months, while less than 5% of patients with ES-SCLC survive two years and the five-year survival rate is 1% to 2%, highlighting the significant unmet need in this area.

Opdivo is already approved for various indications across melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), classical Hodgkin lymphoma (cHL), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) and hepatocellular carcinoma (HCC).